Schering-Plough Annual Meeting Highlights Worldwide Performance, Commitment to Resolving Manufacturing Issues

Apr 24, 2001, 01:00 ET from Schering-Plough Corporation

    KENILWORTH, N.J., April 24 /PRNewswire Interactive News Release/ --
 Schering-Plough Corporation  (NYSE:   SGP) is moving deliberately and
 methodically to address manufacturing issues and improve quality systems on a
 global basis, the company reported at its annual meeting with shareholders
 here today.
     In his remarks to shareholders, Richard Jay Kogan, chairman and chief
 executive officer, said the company has given itself three benchmarks in
 addressing these issues: first, to secure the confidence of the U.S. Food and
 Drug Administration (FDA) concerning its manufacturing systems and controls;
 second, to assure that Schering-Plough has a culture and a system that will
 sustain compliance throughout the organization; and third, to reward
 shareholders with results.
     "Schering-Plough is a strong company, with a proud history and a promising
 future," Kogan told shareholders.  "From 1995 through last year, we nearly
 doubled sales, more than doubled earnings per share and more than doubled our
 annual investments in research and development," he continued.
     Kogan today also reported that the company's Board of Directors authorized
 a 14 percent increase in the quarterly dividend, from 14 cents to 16 cents per
 share, marking the 18th increase in the dividend since 1986.  Kogan said the
 Board's action "reflects our confidence in the financial strength of the
 company and our commitment to reward shareholders."
     While 2000 was another successful year for Schering-Plough, Kogan observed
 that this is not a "normal time" for the company, acknowledging that "now
 we've run into some difficulties."  Referring to the manufacturing issues, he
 said, "We are working through them and I am confident we will come out of this
 with our fundamental strengths intact, wiser and as competitive as ever."
     Schering-Plough on Feb. 15, 2001, reported that the FDA had conducted
 inspections of the company's manufacturing facilities in New Jersey and Puerto
 Rico, and had issued reports citing deficiencies concerning compliance with
 current Good Manufacturing Practices (GMPs), primarily relating to production
 processes, controls and procedures.  Schering-Plough also reported that FDA
 has advised the company that GMP deficiencies cited in facility inspection
 reports must be resolved prior to granting approval of the company's pending
 New Drug Application (NDA) for CLARINEX(TM) (desloratadine) Tablets, a new
 nonsedating antihistamine.
     "CLARINEX has been judged approvable by FDA, and there are no other
 scientific or clinical issues remaining.  So as soon as we can satisfy FDA on
 the manufacturing issues, we expect to see the product approved and launched
 rapidly into the U.S. market.  We are already marketing the product in several
 European countries," Kogan said.
     On an immediate basis, the company is addressing the issues cited in the
 FDA's inspection reports and dedicating the appropriate resources, including
 personnel, equipment and training.
     "We are working to complete the GMP initiatives begun in 1999 and are in
 the process of completing a new comprehensive GMP work plan," Kogan told the
 audience.  "This plan takes a broad, systemic approach that will encompass all
 FDA-regulated manufacturing sites and address six key areas:  quality
 assurance, facilities and equipment, materials management, production,
 laboratories, and packaging and labeling," he said.
     "We are increasing the number of people dedicated to quality control and
 compliance," Kogan noted.  "From 1999 to the end of this year, we expect to
 have increased the number of authorized quality-related positions at our
 FDA-regulated sites by 30 percent.  I believe we have the right organizational
 structure and the right people to assure and sustain a culture of compliance
 to meet FDA expectations on a systematic, company-wide basis," he added.
     "I am determined to put Schering-Plough back on a solid growth track,"
 Kogan told shareholders.  "I know this is what you expect from your company's
 management, and that is what we intend to deliver."
     In reviewing the company's 2000 performance, Kogan said Schering-Plough's
 progress was marked by several major accomplishments:
     -- Sales for the year reached $9.8 billion, up 8 percent, and earnings
        per share rose 14 percent to $1.64.
     -- Research and development programs made important progress, as
        evidenced by the five discovery compounds that were recommended to go
        into clinical development in 2000.
     -- In U.S. and leading world markets, the company received eight
        marketing approvals for major products or indications and filed
        14 major regulatory applications.
     -- Ezetimibe, a novel cholesterol absorption inhibitor and product of
        internal research efforts, is in development for U.S. marketing through
        a partnership with Merck & Co., Inc.  Ezetimibe development is focused
        on its use in a once-daily fixed- combination tablet with Zocor(R)
        (simvastatin), Merck's cholesterol-management drug; as a once-daily
        monotherapy; and in co-administration with statins.  Results of
        Phase III monotherapy and co-administration studies are expected to be
        presented at major medical meetings this year.
     -- PEG-INTRON(TM), a longer-acting form of INTRON(R) A alpha interferon,
        has been launched in the United States and the European Union (EU) for
        the treatment of hepatitis C.
     -- PEG-INTRON and REBETOL(R) combination therapy, expected to become a new
        standard of care for hepatitis C, was approved in the EU in March 2001
        and has been granted priority review status by FDA in the United
        States.
     "Schering-Plough has a long history of discovering and developing
 important products," Kogan reminded the audience.  "The company has grown and
 our shareholders have prospered because Schering-Plough has steadily brought
 to market innovative drugs that address unmet medical needs and represent real
 therapeutic advances," he said.
     "Schering-Plough has not lost sight of that objective.  Even as we direct
 resources to address the various manufacturing issues, our scientists are
 conducting world-class research, and our marketing and sales teams are as
 fully engaged and effective as ever," Kogan said.
     Kogan concluded his remarks by saying, "Schering-Plough has proven time
 and again that it is a capable, "can do" company.  We are putting good plans
 in place; we know how to get things done; and we are doing them.  We have the
 opportunity to come out of this difficult period as a stronger company, more
 competitive and better able to reward you -- our shareholders."
     In other business at the annual meeting, shareholders elected Kogan, David
 H. Komansky, Eugene R. McGrath, Donald L. Miller and Richard de J. Osborne for
 three-year terms on the Board of Directors.  Shareholders also ratified the
 designation of Deloitte & Touche LLP as auditors for 2001.  A shareholder
 proposal concerning pharmaceutical pricing was not adopted.
     DISCLOSURE NOTICE:  In addition to historical information, this press
 release includes certain "forward-looking" statements relating to the
 company's business prospects and the expected impact on the company of the
 manufacturing process and control issues described in more detail in the
 company's Feb. 15, 2001, press release.  The reader of this release should
 understand that the resolution of those manufacturing issues, as well as the
 potential impact of those issues on the company's full-year 2001 sales and
 earnings, are subject to substantial risks and uncertainties, and that those
 issues could cause actual results to differ materially from the company's
 forward-looking statements.  For a full description of those risks and
 uncertainties, the reader of this release is encouraged to read the Disclosure
 Notice in the company's Feb. 15, 2001, press release, which is available on
 the company's Web site at http://www.schering-plough.com.  In addition to the
 risks and uncertainties relating to the company's manufacturing deficiencies,
 the company's forward-looking statements relating to, among other things,
 business prospects and research pipeline, may also be adversely affected by
 general market factors, competitive product development, product availability,
 federal and state regulations and legislation, the regulatory process for new
 products and indications, new manufacturing issues that may  arise, trade
 buying patterns, patent positions, litigation and  investigations.  For
 further details and a discussion of these and other risks and uncertainties,
 see the company's Securities and Exchange Commission filings, including the
 company's 2000 annual report on Form 10-K.
     Schering-Plough Corporation is a research-based company engaged in the
 discovery, development, manufacturing and marketing of pharmaceutical products
 worldwide.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X59997822
 
 

SOURCE Schering-Plough Corporation
    KENILWORTH, N.J., April 24 /PRNewswire Interactive News Release/ --
 Schering-Plough Corporation  (NYSE:   SGP) is moving deliberately and
 methodically to address manufacturing issues and improve quality systems on a
 global basis, the company reported at its annual meeting with shareholders
 here today.
     In his remarks to shareholders, Richard Jay Kogan, chairman and chief
 executive officer, said the company has given itself three benchmarks in
 addressing these issues: first, to secure the confidence of the U.S. Food and
 Drug Administration (FDA) concerning its manufacturing systems and controls;
 second, to assure that Schering-Plough has a culture and a system that will
 sustain compliance throughout the organization; and third, to reward
 shareholders with results.
     "Schering-Plough is a strong company, with a proud history and a promising
 future," Kogan told shareholders.  "From 1995 through last year, we nearly
 doubled sales, more than doubled earnings per share and more than doubled our
 annual investments in research and development," he continued.
     Kogan today also reported that the company's Board of Directors authorized
 a 14 percent increase in the quarterly dividend, from 14 cents to 16 cents per
 share, marking the 18th increase in the dividend since 1986.  Kogan said the
 Board's action "reflects our confidence in the financial strength of the
 company and our commitment to reward shareholders."
     While 2000 was another successful year for Schering-Plough, Kogan observed
 that this is not a "normal time" for the company, acknowledging that "now
 we've run into some difficulties."  Referring to the manufacturing issues, he
 said, "We are working through them and I am confident we will come out of this
 with our fundamental strengths intact, wiser and as competitive as ever."
     Schering-Plough on Feb. 15, 2001, reported that the FDA had conducted
 inspections of the company's manufacturing facilities in New Jersey and Puerto
 Rico, and had issued reports citing deficiencies concerning compliance with
 current Good Manufacturing Practices (GMPs), primarily relating to production
 processes, controls and procedures.  Schering-Plough also reported that FDA
 has advised the company that GMP deficiencies cited in facility inspection
 reports must be resolved prior to granting approval of the company's pending
 New Drug Application (NDA) for CLARINEX(TM) (desloratadine) Tablets, a new
 nonsedating antihistamine.
     "CLARINEX has been judged approvable by FDA, and there are no other
 scientific or clinical issues remaining.  So as soon as we can satisfy FDA on
 the manufacturing issues, we expect to see the product approved and launched
 rapidly into the U.S. market.  We are already marketing the product in several
 European countries," Kogan said.
     On an immediate basis, the company is addressing the issues cited in the
 FDA's inspection reports and dedicating the appropriate resources, including
 personnel, equipment and training.
     "We are working to complete the GMP initiatives begun in 1999 and are in
 the process of completing a new comprehensive GMP work plan," Kogan told the
 audience.  "This plan takes a broad, systemic approach that will encompass all
 FDA-regulated manufacturing sites and address six key areas:  quality
 assurance, facilities and equipment, materials management, production,
 laboratories, and packaging and labeling," he said.
     "We are increasing the number of people dedicated to quality control and
 compliance," Kogan noted.  "From 1999 to the end of this year, we expect to
 have increased the number of authorized quality-related positions at our
 FDA-regulated sites by 30 percent.  I believe we have the right organizational
 structure and the right people to assure and sustain a culture of compliance
 to meet FDA expectations on a systematic, company-wide basis," he added.
     "I am determined to put Schering-Plough back on a solid growth track,"
 Kogan told shareholders.  "I know this is what you expect from your company's
 management, and that is what we intend to deliver."
     In reviewing the company's 2000 performance, Kogan said Schering-Plough's
 progress was marked by several major accomplishments:
     -- Sales for the year reached $9.8 billion, up 8 percent, and earnings
        per share rose 14 percent to $1.64.
     -- Research and development programs made important progress, as
        evidenced by the five discovery compounds that were recommended to go
        into clinical development in 2000.
     -- In U.S. and leading world markets, the company received eight
        marketing approvals for major products or indications and filed
        14 major regulatory applications.
     -- Ezetimibe, a novel cholesterol absorption inhibitor and product of
        internal research efforts, is in development for U.S. marketing through
        a partnership with Merck & Co., Inc.  Ezetimibe development is focused
        on its use in a once-daily fixed- combination tablet with Zocor(R)
        (simvastatin), Merck's cholesterol-management drug; as a once-daily
        monotherapy; and in co-administration with statins.  Results of
        Phase III monotherapy and co-administration studies are expected to be
        presented at major medical meetings this year.
     -- PEG-INTRON(TM), a longer-acting form of INTRON(R) A alpha interferon,
        has been launched in the United States and the European Union (EU) for
        the treatment of hepatitis C.
     -- PEG-INTRON and REBETOL(R) combination therapy, expected to become a new
        standard of care for hepatitis C, was approved in the EU in March 2001
        and has been granted priority review status by FDA in the United
        States.
     "Schering-Plough has a long history of discovering and developing
 important products," Kogan reminded the audience.  "The company has grown and
 our shareholders have prospered because Schering-Plough has steadily brought
 to market innovative drugs that address unmet medical needs and represent real
 therapeutic advances," he said.
     "Schering-Plough has not lost sight of that objective.  Even as we direct
 resources to address the various manufacturing issues, our scientists are
 conducting world-class research, and our marketing and sales teams are as
 fully engaged and effective as ever," Kogan said.
     Kogan concluded his remarks by saying, "Schering-Plough has proven time
 and again that it is a capable, "can do" company.  We are putting good plans
 in place; we know how to get things done; and we are doing them.  We have the
 opportunity to come out of this difficult period as a stronger company, more
 competitive and better able to reward you -- our shareholders."
     In other business at the annual meeting, shareholders elected Kogan, David
 H. Komansky, Eugene R. McGrath, Donald L. Miller and Richard de J. Osborne for
 three-year terms on the Board of Directors.  Shareholders also ratified the
 designation of Deloitte & Touche LLP as auditors for 2001.  A shareholder
 proposal concerning pharmaceutical pricing was not adopted.
     DISCLOSURE NOTICE:  In addition to historical information, this press
 release includes certain "forward-looking" statements relating to the
 company's business prospects and the expected impact on the company of the
 manufacturing process and control issues described in more detail in the
 company's Feb. 15, 2001, press release.  The reader of this release should
 understand that the resolution of those manufacturing issues, as well as the
 potential impact of those issues on the company's full-year 2001 sales and
 earnings, are subject to substantial risks and uncertainties, and that those
 issues could cause actual results to differ materially from the company's
 forward-looking statements.  For a full description of those risks and
 uncertainties, the reader of this release is encouraged to read the Disclosure
 Notice in the company's Feb. 15, 2001, press release, which is available on
 the company's Web site at http://www.schering-plough.com.  In addition to the
 risks and uncertainties relating to the company's manufacturing deficiencies,
 the company's forward-looking statements relating to, among other things,
 business prospects and research pipeline, may also be adversely affected by
 general market factors, competitive product development, product availability,
 federal and state regulations and legislation, the regulatory process for new
 products and indications, new manufacturing issues that may  arise, trade
 buying patterns, patent positions, litigation and  investigations.  For
 further details and a discussion of these and other risks and uncertainties,
 see the company's Securities and Exchange Commission filings, including the
 company's 2000 annual report on Form 10-K.
     Schering-Plough Corporation is a research-based company engaged in the
 discovery, development, manufacturing and marketing of pharmaceutical products
 worldwide.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X59997822
 
 SOURCE  Schering-Plough Corporation

RELATED LINKS

http://www.sch-plough.com